P840001S422

None

FDA Premarket Approval P840001 S422

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

DeviceP840001S422
Classification NameNone
Applicant
PMAP840001
SupplementS422

Supplemental Filings

Supplement NumberDateSupplement Type
P840001Original Filing
S446 2019-09-27 30-day Notice
S445 2019-09-23 Special (immediate Track)
S444 2019-09-16 30-day Notice
S443 2019-08-30 30-day Notice
S442 2019-08-19 30-day Notice
S441 2019-07-29 30-day Notice
S440
S439 2019-07-16 30-day Notice
S438 2019-07-01 30-day Notice
S437 2019-06-06 30-day Notice
S436 2019-05-06 30-day Notice
S435 2019-04-30 30-day Notice
S434 2019-04-26 30-day Notice
S433 2019-04-24 30-day Notice
S432 2019-04-17 30-day Notice
S431 2019-04-16 30-day Notice
S430 2019-04-05 30-day Notice
S429 2019-04-02 30-day Notice
S428 2019-04-01 30-day Notice
S427
S426 2019-03-21 Special (immediate Track)
S425
S424 2019-03-07 30-day Notice
S423 2019-03-04 30-day Notice
S422
S421 2019-02-21 30-day Notice
S420 2019-02-13 30-day Notice
S419 2018-12-26 Real-time Process
S418 2018-12-11 30-day Notice
S417 2018-12-11 30-day Notice
S416 2018-11-19 Special (immediate Track)
S415 2018-11-13 30-day Notice
S414 2018-11-06 30-day Notice
S413 2018-10-30 30-day Notice
S412 2018-10-25 30-day Notice
S411 2018-10-19 30-day Notice
S410 2018-10-10 30-day Notice
S409 2018-10-09 30-day Notice
S408 2018-10-01 30-day Notice
S407 2018-09-14 30-day Notice
S406 2018-09-04 135 Review Track For 30-day Notice
S405
S404 2018-08-02 30-day Notice
S403 2018-07-17 30-day Notice
S402 2018-06-18 30-day Notice
S401 2018-05-24 30-day Notice
S400 2018-05-24 30-day Notice
S399 2018-05-16 30-day Notice
S398 2018-05-07 30-day Notice
S397 2018-05-02 30-day Notice
S396 2018-04-26 30-day Notice
S395 2018-04-16 30-day Notice
S394 2018-03-22 30-day Notice
S393 2018-03-15 Special (immediate Track)
S392 2018-03-14 30-day Notice
S391 2018-03-12 30-day Notice
S390 2018-01-05 135 Review Track For 30-day Notice
S389 2017-12-18 30-day Notice
S388 2017-12-15 30-day Notice
S387 2017-12-12 30-day Notice
S386 2017-11-20 30-day Notice
S385 2017-11-20 30-day Notice
S384
S383 2017-11-13 30-day Notice
S382 2017-11-06 30-day Notice
S381 2017-10-20 30-day Notice
S380 2017-09-27 30-day Notice
S379 2017-09-13 30-day Notice
S378 2017-09-08 30-day Notice
S377 2017-09-05 Normal 180 Day Track No User Fee
S376 2017-09-01 Normal 180 Day Track No User Fee
S375 2017-08-24 30-day Notice
S374 2017-08-22 135 Review Track For 30-day Notice
S373 2017-08-03 135 Review Track For 30-day Notice
S372 2017-08-02 30-day Notice
S371 2017-08-02 30-day Notice
S370 2017-07-27 30-day Notice
S369 2017-07-27 30-day Notice
S368 2017-07-17 30-day Notice
S367 2017-07-17 Real-time Process
S366 2017-07-17 30-day Notice
S365 2017-06-07 Real-time Process
S364 2017-05-23 30-day Notice
S363 2017-05-18 30-day Notice
S362 2017-05-03 30-day Notice
S361 2017-04-28 30-day Notice
S360 2017-04-26 30-day Notice
S359 2017-04-25 30-day Notice
S358 2017-04-14 30-day Notice
S357 2017-04-03 30-day Notice
S356 2017-04-03 30-day Notice
S355 2017-03-29 30-day Notice
S354 2017-03-09 30-day Notice
S353 2017-03-03 30-day Notice
S352 2017-01-13 Special (immediate Track)
S351 2017-01-13 30-day Notice
S350 2017-01-11 30-day Notice
S349 2017-01-09 30-day Notice
S348 2016-11-23 30-day Notice
S347 2016-11-21 30-day Notice
S346 2016-11-14 30-day Notice
S345 2016-11-03 30-day Notice
S344 2016-10-24 Normal 180 Day Track
S343 2016-08-31 Special (immediate Track)
S342 2016-08-15 30-day Notice
S341 2016-08-15 30-day Notice
S340 2016-08-12 30-day Notice
S339 2016-08-01 30-day Notice
S338 2016-07-29 30-day Notice
S337 2016-07-25 30-day Notice
S336 2016-07-20 30-day Notice
S335 2016-06-30 30-day Notice
S334 2016-06-27 30-day Notice
S333 2016-06-27 30-day Notice
S332 2016-06-09 30-day Notice
S331 2016-06-09 30-day Notice
S330 2016-06-07 30-day Notice
S329 2016-06-06 30-day Notice
S328 2016-05-31 30-day Notice
S327 2016-04-27 30-day Notice
S326 2016-04-05 30-day Notice
S325 2016-03-04 30-day Notice
S324 2016-02-29 30-day Notice
S323 2016-02-12 30-day Notice
S322 2016-02-11 30-day Notice
S321 2016-02-08 Normal 180 Day Track
S320 2015-12-28 30-day Notice
S319 2015-12-23 30-day Notice
S318 2015-11-23 30-day Notice
S317 2015-11-03 30-day Notice
S316 2015-10-29 30-day Notice
S315 2015-10-13 30-day Notice
S314 2015-09-30 30-day Notice
S313 2015-09-14 30-day Notice
S312 2015-08-31 135 Review Track For 30-day Notice
S311 2015-08-28 Real-time Process
S310 2015-08-07 30-day Notice
S309 2015-07-23 30-day Notice
S308 2015-06-19 Normal 180 Day Track
S307 2015-06-17 30-day Notice
S306 2015-06-16 30-day Notice
S305 2015-06-08 30-day Notice
S304 2015-06-01 30-day Notice
S303 2015-05-28 Special (immediate Track)
S302 2015-05-15 30-day Notice
S301 2015-05-11 30-day Notice
S300 2015-04-28 30-day Notice
S299 2015-03-23 30-day Notice
S298 2015-03-19 30-day Notice
S297 2015-03-09 30-day Notice
S296 2015-03-06 30-day Notice
S295 2015-02-27 30-day Notice
S294 2015-02-18 30-day Notice
S293 2015-02-04 30-day Notice
S292 2015-01-23 30-day Notice
S291 2015-01-20 30-day Notice
S290 2015-01-12 30-day Notice
S289 2015-01-12 30-day Notice
S288 2015-01-09 30-day Notice
S287 2014-12-16 30-day Notice
S286 2014-11-24 30-day Notice
S285 2014-09-16 30-day Notice
S284 2014-09-16 30-day Notice
S283 2014-09-04 30-day Notice
S282 2014-08-25 30-day Notice
S281 2014-08-20 30-day Notice
S280 2014-08-01 30-day Notice
S279 2014-07-30 30-day Notice
S278 2014-07-21 30-day Notice
S277 2014-07-11 30-day Notice
S276 2014-07-03 30-day Notice
S275 2014-07-02 30-day Notice
S274 2014-06-26 30-day Notice
S273 2014-06-19 Normal 180 Day Track
S272 2014-06-17 30-day Notice
S271 2014-06-04 30-day Notice
S270 2014-06-02 30-day Notice
S269 2014-05-30 30-day Notice
S268 2014-04-25 30-day Notice
S267 2014-03-31 Special (immediate Track)
S266 2014-03-28 30-day Notice
S265 2014-03-13 30-day Notice
S264 2014-03-11 30-day Notice
S263 2014-03-05 30-day Notice
S262 2014-02-18 30-day Notice
S261 2014-02-11 Special (immediate Track)
S260 2014-02-04 135 Review Track For 30-day Notice
S259 2013-12-23 30-day Notice
S258 2013-11-13 30-day Notice
S257 2013-11-12 30-day Notice
S256 2013-11-01 30-day Notice
S255 2013-10-25 30-day Notice
S254 2013-10-22 30-day Notice
S253 2013-09-30 30-day Notice
S252 2013-09-24 30-day Notice
S251 2013-09-23 30-day Notice
S250 2013-09-23 30-day Notice
S249 2013-09-16 30-day Notice
S248 2013-09-13 30-day Notice
S247 2013-09-09 30-day Notice
S246 2013-07-29 30-day Notice
S245 2013-07-17 30-day Notice
S244 2013-07-12 30-day Notice
S243 2013-07-03 30-day Notice
S242 2013-06-06 Real-time Process
S241 2013-05-31 135 Review Track For 30-day Notice
S240 2013-05-07 30-day Notice
S239 2013-04-16 30-day Notice
S238 2013-04-10 135 Review Track For 30-day Notice
S237 2013-03-18 30-day Notice
S236 2013-02-11 Real-time Process
S235 2013-02-08 135 Review Track For 30-day Notice
S234 2013-02-07 Real-time Process
S233 2013-02-01 30-day Notice
S232 2013-01-22 30-day Notice
S231 2012-12-11 30-day Notice
S230 2012-10-05 Real-time Process
S229 2012-10-04 30-day Notice
S228 2012-09-25 30-day Notice
S227 2012-09-10 30-day Notice
S226 2012-08-20 30-day Notice
S225 2012-08-14 30-day Notice
S224 2012-07-25 30-day Notice
S223 2012-07-23 135 Review Track For 30-day Notice
S222 2012-07-19 30-day Notice
S221 2012-07-16 Real-time Process
S220 2012-07-13 30-day Notice
S219 2012-07-03 Normal 180 Day Track
S218 2012-07-02 30-day Notice
S217 2012-05-17 30-day Notice
S216 2012-05-09 30-day Notice
S215 2012-05-09 30-day Notice
S214 2012-05-07 30-day Notice
S213 2012-04-30 30-day Notice
S212 2012-04-10 30-day Notice
S211 2012-04-05 Real-time Process
S210 2012-04-04 Special (immediate Track)
S209 2012-04-02 30-day Notice
S208 2012-03-27 Real-time Process
S207 2012-03-26 30-day Notice
S206 2012-03-22 30-day Notice
S205 2012-03-16 30-day Notice
S204
S203 2011-12-21 30-day Notice
S202 2011-12-16 30-day Notice
S201 2011-12-14 30-day Notice
S200 2011-12-08 30-day Notice
S199 2011-11-15 Normal 180 Day Track
S198 2011-11-04 30-day Notice
S197 2011-10-11 30-day Notice
S196 2011-09-22 30-day Notice
S195 2011-07-29 Special (immediate Track)
S194 2011-07-22 30-day Notice
S193 2011-07-19 30-day Notice
S192 2011-07-06 30-day Notice
S191 2011-06-29 30-day Notice
S190 2011-06-10 30-day Notice
S189 2011-06-06 30-day Notice
S188 2011-05-23 30-day Notice
S187 2011-05-20 30-day Notice
S186 2011-05-18 30-day Notice
S185 2011-05-16 Normal 180 Day Track
S184 2011-04-18 135 Review Track For 30-day Notice
S183 2011-04-04 30-day Notice
S182 2011-03-16 135 Review Track For 30-day Notice
S181 2011-02-16 30-day Notice
S180 2011-02-07 30-day Notice
S179 2011-02-07 30-day Notice
S178 2011-02-03 Real-time Process
S177
S176 2010-12-27 30-day Notice
S175 2010-12-21 Special (immediate Track)
S174 2010-12-13 30-day Notice
S173 2010-12-08 30-day Notice
S172 2010-12-07 30-day Notice
S171 2010-11-26 30-day Notice
S170 2010-11-24 30-day Notice
S169 2010-11-22 30-day Notice
S168 2010-10-25 30-day Notice
S167 2010-10-12 30-day Notice
S166
S165 2010-09-14 30-day Notice
S164 2010-08-31 30-day Notice
S163 2010-08-17 30-day Notice
S162 2010-08-11 30-day Notice
S161 2010-08-11 30-day Notice
S160 2010-07-30 30-day Notice
S159 2010-08-02 Normal 180 Day Track
S158 2010-07-08 135 Review Track For 30-day Notice
S157 2010-06-30 30-day Notice
S156 2010-06-28 30-day Notice
S155 2010-06-03 30-day Notice
S154 2010-06-01 30-day Notice
S153 2010-04-27 30-day Notice
S152 2010-04-20 30-day Notice
S151 2010-04-15 30-day Notice
S150 2010-04-02 30-day Notice
S149 2010-03-19 30-day Notice
S148 2010-02-01 30-day Notice
S147 2010-02-01 30-day Notice
S146 2010-01-27 30-day Notice
S145 2010-01-12 30-day Notice
S144 2009-12-23 30-day Notice
S143 2010-01-07 Real-time Process
S142 2009-12-14 30-day Notice
S141 2009-08-24 Normal 180 Day Track No User Fee
S140 2009-08-20 30-day Notice
S139 2009-05-18 30-day Notice
S138 2009-04-21 30-day Notice
S137 2009-04-14 30-day Notice
S136 2009-04-09 Real-time Process
S135 2009-04-07 135 Review Track For 30-day Notice
S134 2009-03-13 135 Review Track For 30-day Notice
S133 2009-03-09 30-day Notice
S132 2009-02-24 30-day Notice
S131 2009-02-23 Real-time Process
S130 2009-02-12 30-day Notice
S129 2009-02-06 30-day Notice
S128 2009-02-05 Real-time Process
S127 2009-01-02 30-day Notice
S126 2008-12-24 Normal 180 Day Track
S125 2008-12-17 30-day Notice
S124 2008-12-15 30-day Notice
S123 2008-12-11 Normal 180 Day Track No User Fee
S122 2008-10-08 Real-time Process
S121 2008-10-07 30-day Notice
S120
S119 2008-08-18 30-day Notice
S118 2008-07-24 135 Review Track For 30-day Notice
S117 2008-06-30 135 Review Track For 30-day Notice
S116
S115 2008-06-12 30-day Notice
S114 2008-06-02 30-day Notice
S113 2008-05-16 30-day Notice
S112 2008-04-23 30-day Notice
S111 2008-04-03 135 Review Track For 30-day Notice
S110 2008-03-26 30-day Notice
S109 2008-03-20 30-day Notice
S108 2008-03-11 30-day Notice
S107 2008-03-10 135 Review Track For 30-day Notice
S106 2008-02-25 30-day Notice
S105 2007-12-21 30-day Notice
S104 2007-11-23 30-day Notice
S103 2007-11-19 30-day Notice
S102 2007-10-19 Real-time Process
S101 2007-10-09 30-day Notice
S100 2007-10-05 135 Review Track For 30-day Notice
S099 2007-09-17 135 Review Track For 30-day Notice
S098 2007-08-31 Real-time Process
S097 2007-05-18 Normal 180 Day Track
S096 2007-03-23 Real-time Process
S095 2006-12-28 Real-time Process
S094
S093 2006-05-15 Real-time Process
S092 2006-05-12 Normal 180 Day Track
S091 2006-01-20 Special (immediate Track)
S090 2005-12-19 Real-time Process
S089 2005-12-16 Real-time Process
S088 2005-11-30 Real-time Process
S087
S086 2005-11-02 30-day Notice
S085
S084 2005-11-28 Real-time Process
S083 2005-10-06 135 Review Track For 30-day Notice
S082 2005-09-06 Real-time Process
S081 2005-08-23 Real-time Process
S080 2005-08-05 Real-time Process
S079
S078
S077 2004-12-02 Normal 180 Day Track
S076 2004-12-01 Normal 180 Day Track
S075 2004-10-18 Normal 180 Day Track
S074 2004-10-12 Normal 180 Day Track
S073 2004-05-19 Real-time Process
S072 2004-03-04 Real-time Process
S071 2003-08-25 Normal 180 Day Track No User Fee
S070 2003-08-19 Real-time Process
S069 2003-07-21 Normal 180 Day Track
S068 2003-04-07 Special (immediate Track)
S067 2003-03-24 Real-time Process
S066 2002-09-13 Real-time Process
S065 2002-08-01 Real-time Process
S064 2002-06-24 Normal 180 Day Track
S063 2002-05-22 Special (immediate Track)
S062 2002-05-20 Real-time Process
S061 2002-05-10 Normal 180 Day Track
S060 2001-12-07 30-day Notice
S059 2001-11-13 Special (immediate Track)
S058 2001-10-22 Real-time Process
S057
S056
S055 2001-07-10 Special (immediate Track)
S054 2001-05-23 Special (immediate Track)
S053 2001-04-16 Normal 180 Day Track
S052 2001-04-10 Normal 180 Day Track
S051 2001-02-01 Normal 180 Day Track
S050 2001-01-29 Normal 180 Day Track
S049 2000-11-16 30-day Notice
S048
S047 2000-06-01 Normal 180 Day Track
S046 2000-02-10 Real-time Process
S045 2000-01-24 Real-time Process
S044 2000-01-18 Real-time Process
S043 1999-01-12 Real-time Process
S042 1998-10-01 Normal 180 Day Track
S041 1997-07-24 Normal 180 Day Track
S040 1996-02-06 Normal 180 Day Track
S039 1995-08-08 Normal 180 Day Track
S038 1995-06-29 Normal 180 Day Track
S037 1995-01-17 Normal 180 Day Track
S036 1994-12-20 Normal 180 Day Track
S035 1994-11-03 Normal 180 Day Track
S034 1994-07-29 Normal 180 Day Track
S033
S032 1994-04-20 Normal 180 Day Track
S031 1994-02-15 Normal 180 Day Track
S030 1994-02-07 Normal 180 Day Track
S029 1993-07-20 Normal 180 Day Track
S028 1992-11-12 Normal 180 Day Track
S027
S026 1992-02-10 Normal 180 Day Track
S025 1991-10-03 Normal 180 Day Track
S024 1991-04-01 Normal 180 Day Track
S023 1991-02-07 Normal 180 Day Track
S022 1990-09-04 Normal 180 Day Track
S021 1990-06-06 Normal 180 Day Track
S020 1990-04-04 Normal 180 Day Track
S019 1990-02-13 Normal 180 Day Track
S018 1990-01-18 Normal 180 Day Track
S017 1989-05-03 Normal 180 Day Track
S016 1989-04-02 Normal 180 Day Track
S015 1989-01-25 Normal 180 Day Track
S014 1988-10-03 Normal 180 Day Track
S013 1988-07-29 Normal 180 Day Track
S012 1988-07-05 Normal 180 Day Track
S011 1987-07-22 Normal 180 Day Track
S010 1987-07-15 Normal 180 Day Track
S009 1987-05-26 Normal 180 Day Track
S008 1986-06-11 Normal 180 Day Track
S007 1986-04-11
S006 1986-04-04
S005 1985-11-07
S004 1985-04-10 Normal 180 Day Track
S003 1985-03-20
S002 1985-02-13 Normal 180 Day Track
S001 1985-01-18 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00613994367402 P840001 000
00613994190031 P840001 000
00613994190031 P840001 000
00613994367402 P840001 000
20613994518853 P840001 020
20613994518853 P840001 020
00613994362933 P840001 042
00613994362933 P840001 042
00613994363251 P840001 050
00673978933733 P840001 050
00613994363251 P840001 050
00673978933733 P840001 050
00681490518031 P840001 062
00681490518031 P840001 062
00613994354358 P840001 062
00613994354358 P840001 062
00721902339158 P840001 064
00721902339134 P840001 064
00721902339134 P840001 064
00721902339158 P840001 064
00721902662423 P840001 066
00721902593741 P840001 066
00721902593734 P840001 066
00721902593642 P840001 066
00721902593659 P840001 066
00721902593741 P840001 066
00721902593642 P840001 066
00721902593659 P840001 066
00721902662423 P840001 066
00721902593734 P840001 066
00673978926438 P840001 070
00673978926438 P840001 070
00613994300485 P840001 072
00613994722171 P840001 072
00613994722140 P840001 072
00613994300492 P840001 072
00613994722126 P840001 072
00613994722096 P840001 072
00613994457219 P840001 072
00613994722089 P840001 072
00613994300485 P840001 072
00613994722133 P840001 072
00613994300478 P840001 072
00613994722188 P840001 072
00613994300492 P840001 072
00613994300515 P840001 072
00613994300522 P840001 072
00613994300461 P840001 072
00613994300553 P840001 072
00613994300560 P840001 072
00613994300515 P840001 072
00613994300553 P840001 072
00613994237613 P840001 072
00613994300522 P840001 072
00613994300478 P840001 072
00613994722140 P840001 072
00885074478968 P840001 072
00613994722133 P840001 072
00613994722126 P840001 072
00885074478968 P840001 072
00613994457219 P840001 072
00885074471976 P840001 072
00613994722089 P840001 072
00613994300546 P840001 072
00613994237613 P840001 072
00613994722188 P840001 072
00613994722171 P840001 072
00613994300461 P840001 072
00613994300546 P840001 072
00613994300560 P840001 072
00885074471969 P840001 072
00885074471969 P840001 072
00885074471976 P840001 072
00613994722096 P840001 072
00885074087368 P840001 073
00885074087382 P840001 073
00885074087351 P840001 073
00613994188342 P840001 074
00613994188335 P840001 074
00613994353641 P840001 074
00613994188342 P840001 074
00613994188335 P840001 074
00643169157545 P840001 074
00643169157552 P840001 074
00643169157569 P840001 074
00643169157583 P840001 074
00643169157583 P840001 074
00643169157545 P840001 074
00643169157538 P840001 074
00643169157569 P840001 074
00885074384528 P840001 074
00885074237121 P840001 074
00885074050645 P840001 074
00613994353641 P840001 074
00885074237121 P840001 074
00885074384528 P840001 074
00643169157552 P840001 074
00643169157538 P840001 074
00643169157347 P840001 075
00643169157330 P840001 075
00613994721952 P840001 075
00643169157316 P840001 075
00721902532825 P840001 075
00613994188632 P840001 075
00643169157309 P840001 075
00643169157323 P840001 075
00643169157354 P840001 075
00643169157309 P840001 075
00643169157446 P840001 075
00643169157323 P840001 075
00643169157330 P840001 075
00643169157347 P840001 075
00643169157354 P840001 075
00643169157446 P840001 075
00643169157453 P840001 075
00613994721945 P840001 075
00613994721938 P840001 075
00721902532825 P840001 075
00643169157453 P840001 075
00613994721921 P840001 075
00613994721914 P840001 075
00613994721907 P840001 075
00643169157316 P840001 075
00885074291802 P840001 075
00613994188687 P840001 075
00613994188670 P840001 075
00613994188663 P840001 075
00613994188656 P840001 075
00613994188632 P840001 075
00613994188649 P840001 075
00613994188656 P840001 075
00613994721952 P840001 075
00885074200194 P840001 075
00885074330747 P840001 075
00885074291802 P840001 075
00885074200330 P840001 075
00885074200323 P840001 075
00885074200293 P840001 075
00885074200279 P840001 075
00885074200248 P840001 075
00885074291932 P840001 075
00885074200224 P840001 075
00613994721938 P840001 075
00613994721945 P840001 075
00613994188670 P840001 075
00613994721907 P840001 075
00885074330747 P840001 075
00613994721914 P840001 075
00613994721921 P840001 075
00613994188663 P840001 075
00613994188687 P840001 075
00885074291932 P840001 075
00613994188649 P840001 075
00885074164267 P840001 077
00643169157507 P840001 082
00613994721877 P840001 082
00613994721860 P840001 082
00643169157484 P840001 082
00613994721877 P840001 082
00643169157477 P840001 082
00643169157460 P840001 082
00643169157491 P840001 082
00643169157507 P840001 082
00643169157484 P840001 082
00643169157491 P840001 082
00643169157477 P840001 082
00643169157460 P840001 082
00613994188700 P840001 082
00613994199157 P840001 082
00613994721884 P840001 082
00613994188700 P840001 082
00613994721884 P840001 082
00613994188694 P840001 082
00613994199157 P840001 082
00613994721860 P840001 082
00613994188694 P840001 082
00613994188717 P840001 082
00613994188717 P840001 082
00613994374684 P840001 097
00643169513013 P840001 097
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